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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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WELLBRACE - 07798094547794

CABESTRILLO DE RED- WELLBRACE - L
PANTYMED S.A.
1104-502 U L
In Commercial Distribution

  • 07798094547794 ()


  • Limb-worn device hygienic cover

WELLBRACE - 07798094547787

CABESTRILLO DE RED- WELLBRACE - M
PANTYMED S.A.
1104-502 U M
In Commercial Distribution

  • 07798094547787 ()


  • Limb-worn device hygienic cover

WELLBRACE - 07798094547770

CABESTRILLO DE RED- WELLBRACE - S
PANTYMED S.A.
1104-502 U S
In Commercial Distribution

  • 07798094547770 ()


  • Limb-worn device hygienic cover

WELLBRACE - 07798094540115

CABESTRILLO DOBLE SUJECION - W - L
PANTYMED S.A.
1104-501N U L
In Commercial Distribution

  • 07798094540115 ()


  • Limb-worn device hygienic cover

WELLBRACE - 07798094540108

CABESTRILLO DOBLE SUJECION - W - M
PANTYMED S.A.
1104-501N U M
In Commercial Distribution

  • 07798094540108 ()


  • Limb-worn device hygienic cover

WELLBRACE - 07798094540092

CABESTRILLO DOBLE SUJECION - W - S
PANTYMED S.A.
1104-501N U S
In Commercial Distribution

  • 07798094540092 ()


  • Limb-worn device hygienic cover

WELLBRACE - 07798094540085

CABESTRILLO DOBLE SUJECION - W - XS
PANTYMED S.A.
1104-501N U XS
In Commercial Distribution

  • 07798094540085 ()


  • Limb-worn device hygienic cover

WELLBRACE - 07798094540078

CABESTRILLO DE RED- WELLBRACE - XS
PANTYMED S.A.
1104-502 U XS
In Commercial Distribution

  • 07798094540078 ()


  • Limb-worn device hygienic cover

WELLBRACE - 07798094540061

CABESTRILLO DOBLE SUJECION - W - XS
PANTYMED S.A.
1104-501C U XS
In Commercial Distribution

  • 07798094540061 ()


  • Limb-worn device hygienic cover

Micromed - 08033928120828

The SD LTM STIM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG).
MICROMED SPA
SD LTM STIM
In Commercial Distribution

  • 08033928120828 ()


  • Somatosensory electrical stimulation system

L360 Thigh System - 00815962020382

L360 Thigh System Kit, Left
BIONESS INC.
L4T-6001
In Commercial Distribution

  • 00815962020382 ()


  • Gait-enhancement electrical stimulation system, external

L100 Go System - 00815962020337

L100 Go System, Right
BIONESS INC.
LG1-5Y00
In Commercial Distribution

  • 00815962020337 ()


  • Gait-enhancement electrical stimulation system, external

L300 Go System - 00815962020207

L300 Go System, Right Thigh Stand-Alone
BIONESS INC.
L4T-5000
In Commercial Distribution

  • 00815962020207 ()


  • Gait-enhancement electrical stimulation system, external

L300 Go System, Right Thigh Plus - 00815962020191

L300 Go system with Right Thigh cuff
BIONESS INC.
L4P-5100
In Commercial Distribution

  • 00815962020191 ()


  • Gait-enhancement electrical stimulation system, external

L300 Go System, Right Small Lower Leg - 00815962020184

L300 Go system with Small Right cuff
BIONESS INC.
LG4-5U00
In Commercial Distribution

  • 00815962020184 ()


  • Gait-enhancement electrical stimulation system, external

L300 Go System, Right Lower Leg - 00815962020177

L300 Go system with Lower Right cuff
BIONESS INC.
LG4-5000
In Commercial Distribution

  • 00815962020177 ()


  • Gait-enhancement electrical stimulation system, external

L300 Go System, Left Thigh Stand-Alone - 00815962020160

L300 Go system with Left Thigh cuff only
BIONESS INC.
L4T-5001
In Commercial Distribution

  • 00815962020160 ()


  • Gait-enhancement electrical stimulation system, external

L300 Go System, Left Thigh Plus - 00815962020153

L300 Go system with Left Thigh cuff
BIONESS INC.
L4P-5001
In Commercial Distribution

  • 00815962020153 ()


  • Gait-enhancement electrical stimulation system, external

L300 Go System, Left Small Lower Leg - 00815962020146

L300 Go system with Small Left cuff
BIONESS INC.
LG4-5V00
In Commercial Distribution

  • 00815962020146 ()


  • Gait-enhancement electrical stimulation system, external

L300 Go System, Left Lower Leg - 00815962020139

L300 Go system with Lower Left cuff
BIONESS INC.
LG4-5100
In Commercial Distribution

  • 00815962020139 ()


  • Gait-enhancement electrical stimulation system, external

L300 Go Clinician Kit - 00815962020115

L300 Go Accessories
BIONESS INC.
LG4-4000
In Commercial Distribution

  • 00815962020115 ()


  • Gait-enhancement electrical stimulation system, external

L300 Go Clinician Programmer Software - 00815962020061

Clinician Programmer Software for L300 Go system
BIONESS INC.
LG4-SW01
In Commercial Distribution

  • 00815962020061 ()


  • Gait-enhancement electrical stimulation system, external

L360 Thigh System - 00815962020399

L360 Thigh System Kit, Right
BIONESS INC.
L4T-6000
In Commercial Distribution

  • 00815962020399 ()


  • Gait-enhancement electrical stimulation system, external

L100 Go System - 00815962020344

L100 Go System, Left
BIONESS INC.
LG1-5X00
In Commercial Distribution

  • 00815962020344 ()


  • Gait-enhancement electrical stimulation system, external

NESS L300 Foot Drop System - 07290110483098

Small L300 System Kit, Right US
BIONESS INC.
LG3-5U00
Not in Commercial Distribution

  • 07290110483098 ()
501-00170-01

  • Gait-enhancement electrical stimulation system, external

NESS L300 Foot Drop System - 07290110483081

Small L300 System Kit, Left US
BIONESS INC.
LG3-5V00
Not in Commercial Distribution

  • 07290110483081 ()
501-00169-01

  • Gait-enhancement electrical stimulation system, external

NESS L300 Foot Drop System - 07290110483074

Regular L300 Clinician's Kit US
BIONESS INC.
LG3-4000
Not in Commercial Distribution

  • 07290110483074 ()
501-00161-01

  • Gait-enhancement electrical stimulation system, external

NESS L300 Foot Drop System - 07290110483067

Regular L300 System Kit, Right US
BIONESS INC.
LG3-5000
Not in Commercial Distribution

  • 07290110483067 ()
501-00159-01

  • Gait-enhancement electrical stimulation system, external

NESS L300 Foot Drop System - 07290110483050

Regular L300 System Kit, Left US
BIONESS INC.
LG3-5100
Not in Commercial Distribution

  • 07290110483050 ()
501-00158-01

  • Gait-enhancement electrical stimulation system, external

NESS L300-Plus System - 07290110483043

L300 Plus US Clinician's Upgrade Kit
BIONESS INC.
L3P-4100
Not in Commercial Distribution

  • 07290110483043 ()
501-00046-01

  • Gait-enhancement electrical stimulation system, external

NESS L300-Plus System - 07290110483036

L300 Plus US Upgrade System Kit, Right (regular)
BIONESS INC.
L3P-5100
Not in Commercial Distribution

  • 07290110483036 ()
501-00127-01

  • Gait-enhancement electrical stimulation system, external

NESS L300-Plus System - 07290110483029

L300 Plus US Upgrade System Kit, Left (regular)
BIONESS INC.
L3P-5101
Not in Commercial Distribution

  • 07290110483029 ()
501-00126-01

  • Gait-enhancement electrical stimulation system, external

NESS L300-Plus System - 07290110483012

L300 Plus US System Kit, Right (regular)
BIONESS INC.
L3P-5000
Not in Commercial Distribution

  • 07290110483012 ()
501-00123-01

  • Gait-enhancement electrical stimulation system, external

NESS L300-Plus System - 07290110483005

L300 Plus US System Kit, Left (regular)
BIONESS INC.
L3P-5001
Not in Commercial Distribution

  • 07290110483005 ()
501-00122-01

  • Gait-enhancement electrical stimulation system, external

USB to Electrical Stimulation Box Cable - 00817020020310

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M014911
In Commercial Distribution

  • 00817020020310 ()


  • Somatosensory electrical stimulation system

Electrical Stimulator Probe - 00817020020303

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M014920
In Commercial Distribution

  • 00817020020303 ()


  • Somatosensory electrical stimulation system

Electrical Stimulation Box - 00817020020297

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M014910
In Commercial Distribution

  • 00817020020297 ()


  • Somatosensory electrical stimulation system

L300 Go System - 00810188050595

Clinician Programmer Software for L300 Go System
Bioness Medical, Inc.
LG4-SW01
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external

L100 Go System - 00810188050168

L100 Go System, Right
Bioness Medical, Inc.
LG1-5Y00
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external

L300 Go System - 00810188050144

L300 Go System, Left Thigh Stand-Alone
Bioness Medical, Inc.
L4T-5001
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external

L300 Go System - 00810188050137

L300 Go System, Right Thigh Stand-Alone
Bioness Medical, Inc.
L4T-5000
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external

L300 Go System - 00810188050113

L300 Go System, Right Thigh Plus
Bioness Medical, Inc.
L4P-5100
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external

L300 Go System - 00810188050106

L300 Go System, Left Small Lower
Bioness Medical, Inc.
LG4-5V00
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external

L300 Go System - 00810188050090

L300 Go System, Right Small Lower
Bioness Medical, Inc.
LG4-5U00
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external

L300 Go System - 00810188050076

L300 Go System, Right Lower
Bioness Medical, Inc.
LG4-5000
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external

L360 Thigh System - 00810188050069

L360 Thigh System Kit, Left
Bioness Medical, Inc.
L4T-6001
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external

L100 Go System - 00810188050175

L100 Go System, Left
Bioness Medical, Inc.
LG1-5X00
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external

L300 Go System - 00810188050120

L300 Go System, Left Thigh Plus
Bioness Medical, Inc.
L4P-5001
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external

L300 Go System - 00810188050083

L300 Go System, Left Lower
Bioness Medical, Inc.
LG4-5100
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external

L360 Thigh System - 00810188050052

L360 Thigh System Kit, Right
Bioness Medical, Inc.
L4T-6000
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external
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